For decades, vaccine developers have relied on immunobridging to speed up approval of updated vaccines. This approach allowed regulators to approve new or modified vaccines by comparing immune responses to those of already-approved vaccines, avoiding lengthy and costly efficacy trials. Now, the U.S. Food and Drug Administration (FDA) is moving away from this shortcut. Instead, it proposes a more rigorous system based on establishing a Correlate of Protection (CoP). This chang

FDA Removes HRT Boxed Warning! Your regulatory team must update labeling and SPL files immediately. Get the 5-step action plan to avoid compliance flags.